Sumitomo Pharma: First iPS-derived Parkinson’s drug transplant

Nikkei Japan

Overview

Sumitomo Pharma has performed the first clinical transplant of its iPS cell-derived Parkinson’s disease treatment, “Amshepri,” following its conditional and time-limited approval in March. The procedure was conducted on a female patient in her 50s at Kyoto University Hospital, who has since returned to work.

In Depth

Key Findings

Sumitomo Pharma has successfully implemented the first clinical transplant of “Amshepri,” a regenerative medicine product derived from iPS cells for the treatment of Parkinson’s disease. The surgery took place in early October at Kyoto University Hospital for a female patient in her 50s. The patient has already been discharged and returned to her workplace, with postoperative progress reported as favorable.

Technical Details

Amshepri utilizes iPS cells derived from donors to create precursor cells that produce dopamine-generating neurons. These cells are transplanted into the patient to improve motor functions. The product has been covered by insurance since May, and there are currently four facilities in Japan capable of performing the transplant surgery.

Background and Context

The product received conditional and time-limited manufacturing and sales approval in March. This specific case marks the first time the treatment has been administered in a clinical setting following that approval. In the broader field of iPS-derived medical products, a heart muscle sheet called “Reheart” from the Osaka University startup Curopis was used in a surgery in September. Amshepri represents the second global instance of an iPS-derived product being used for patient treatment in a clinical environment.

Significance and Outlook

Sumitomo Pharma President Toru Kimura stated that the commencement of these post-marketing clinical trials is a critical step toward achieving full approval. The company’s immediate roadmap for further transplants includes:

• One additional patient by the end of this year.
• Approximately 10 patients in fiscal year 2027.
• Between 10 and 20 patients in fiscal year 2028.

The company intends to prioritize the completion of these trials to secure final approval for the treatment.

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